Biomodule 3-M1
by Zephyr Technology Corporation 510(k)
Active
510(k) K123658
Overview
The Biomodule 3-M1 is a physiological transmitter designed to transmit data to a qualified receiving station. It functions as an electrocardiograph electrode system used to monitor patient data.
This device is used in conjunction with disposable, off-the-shelf electrodes. It is identified under FDA 510(k) number K123658 and is classified as a Class 2 device within the cardiovascular medical specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123658 | Date24 Apr 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2360
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zephyr Technology Corporation
Questions
What is the primary function of the Biomodule 3-M1?
The Biomodule 3-M1 is a physiological transmitter designed to monitor patient data. It functions as an electrocardiograph electrode system that transmits collected data to a qualified receiving station for clinical review.
Does the Biomodule 3-M1 include electrodes?
No, the device does not include electrodes. It is designed to be used in conjunction with standard, disposable, off-the-shelf electrodes to facilitate the monitoring process.
What is the regulatory status of this device?
The Biomodule 3-M1 is identified under FDA 510(k) number K123658. It is classified as a Class 2 device within the cardiovascular medical specialty and was determined to be substantially equivalent to existing devices.